Spinal fusion surgery in the clinical setting has a reported failure (non union) rate of anywhere from 5% to 35%. While many variables are thought to affect the success rate of spine fusion procedures, most attempts to improve the clinical outcome have focused on internal or external fixation techniques that augment the biomechanical stability of the fusion mass. More recently, however, pre-clinical investigations have sought to understand the role and importance of biological and physical factors in the healing and subsequent stabilization of the fusion mass. Electrical stimulation in various forms has been demonstrated to improve the overall fusion rate in clinical populations.
However, current technology uses electrical leads that are implanted in the bony fusion mass, which must be left behind during explantation of the battery cell. Also, patient compliance is an issue with the current techniques employed in clinically attachable bone growth surface electrode stimulators.
Thus, a heretofore unaddressed need exists in the industry to address the aforementioned deficiencies and inadequacies.